Looks like some good news for Lundbeck with the pending approval of a new product, but with all the talk about new commercial models and stuff, and with the recognition that the ‘old model’ was dying – or dead – why would you go down what sounds like a very traditional approach.

So the old model doesn’t look so old when a new product comes along that has potential to be a blockbuster.

It seems that is quite hard to recruit patients into taking part in a clinical trial. And getting harder too.

For those of you who don’t know, these are clinical studies, usually carried out by clinical research organisation on behalf of a pharmaceutical company. They typically involve recruiting patients that match a specific criteria set down by the pharma company, and they are either provided the drug being tested or a placebo sugar pill and the results monitored. Clearly the patient does not know if they are receiving ‘the real deal’ or just a sugar pill. In return the patient receives on going free medical checks, the medication for free and usually some form of fee.

Additionally the patient needs to submit to a series, sometimes quite a rigorous series of tests throughout the course of the trial. And, of course, you may be lucky and receive a new, highly effective new treatment for your condition. Or not!

So, on a recent trip back to the US I was driving down from New York and on the radio that I was only half listening to, there was an advertisement from a CRO (Clinical Research Organisation) recruiting people to take part in an investigational trial. It sort of caught my attention, so I listened a bit more closely to the last part of the advert. The thing that really caught my attention was the ending. It went something like this ‘call this number today if you qualify and be part of this investigational trial’.

I am sure the advert was better than that, but the way it finished left me feeling like it was a competition, and if you met their specifications you were a winner. I felt like this was a very typical mistake made by companies that work in this area and was a fine example of an internal company view without really appreciating the customers perspective.

What the advert should have said was ‘if you are unfortunate enough to have this condition we may be able to help you’. But this advert was only looking at the benefits for the pharma company. We need test subjects, we will pay them money to participate. They may or may not receive the drug they need, but this will help us bring this drug to market or not.

It’s no wonder people don’t want to participate in trials. Forget the ethical issue of folks not receiving a medication that they need, or even telling them they are taking the medicine or not, but pharma and CRO’s need to understand the patients perspective better.

I know the dust has not settled yet, and there is no concrete decision in this latest example of profits before patients. But there is a lot of discussion right now in healthcare circles about pharma’s continued poor behavior in this area.

The latest example comes from our friends at Sanofi and their rare disease division Genzyme.

Global headquarters of Genzyme. (Photo credit: Wikipedia)

Seems there is a drug on market, branded Campath, used in the treatment of leukemia and blood cancer. But has been successful in the treatment of MS patients.

Good news I would say.

But, it seems that there is more money to be made in MS, and so Genzyme is looking at a new pricing structure for Lamtrada – as it is going to be called. One that is 20 – 30 times more expensive than it is today. It is only scuttlebutt, but one would need to question the thinking process behind this.

Why would Genzyme even be contemplating such a move? I can only think of one reason, and it has much less to do with patient outcomes than it does with profit.

Healthcare providers, and, I guess, patients as well, are very unhappy about this. And so they should be. It is not wonder the motives of big pharma are so often challenged and they suffer from a severe case of ‘lack of trust’ by their customers.

Two things need to happen.

The first. Pharma needs to take a long hard look at itself and address this type of thinking that seems so ingrained within the industry. There is nothing wrong with making money, but I guess they have not heard of the concept of ‘bad profits’.

The second thing is that the regulators need to take clear and decisive action to stop this behavior.

How about a medical researcher or in academia? What about if you are working in healthcare?

Why do I ask? Well I just had something of a ‘lights on’ moment. I was watching a great presentation about health literacy from a very prominent and thoughtful clinician and researcher. She had a great presentation – very thought-provoking and also insightful – a great combination.

But listening to her – and let me say that she really ‘get’s this stuff’ that’s clear. But. She get’s it as a clinician. The way she spoke, the terms she used, and the research driven, data based approach to things made it clear to me that one of the biggest issues we have is that healthcare is more about the science and the healthcare practitioners than it is about you and me.

The big debates. Key issues and questions all led by industry insiders. naturally enough taking a science based approach. Where is the expert input from you and me?

But certainly all of pharma! And then much of healthcare – payers, insurance companies, private medicine, even some doctors, although not all.

Notice what’s missing?

Patients! Patients aren’t talking about adherence!

So what is going on here? We all know big pharma is facing a very uncertain future. Lots of big – read profitable – products going off patent, and, of course, the rise in the use of generics, so where to go to continue to grow profits. Of course, everyone is looking to emerging markets, but even there it is becoming clear that the future is not as promising as it once appeared to be, with strong price pressures from governments, massive competition from within big pharma and a market that does not want to be dominated by big international players. So patient adherence is growing in importance.

Healthcare can form a significant part of a country’s economy. In 2008, the healthcare industry consumed an average of 9.0 percent of the GDP across the most developed OECD countries. The United States (16%), France (11.2%) and Switzerland (10.7%) were the top three spenders (Wikipedia).

In the US, that accounts for more than 2.2 trillion dollars per annum.

This is not one of those issues where clearly the more money you throw at the problem the better the outcomes will be.

Yet what does this huge amount of money the US spends each year on healthcare do for the health of the population. Because it does not deliver the best health outcomes the world has to offer (at least according to many) so what does it deliver?

One answer can be: it delivers huge profits to some of the players. With so much money at stake, in the US, companies are competing to expand their share of the pie. Many corporations return considerable profits to shareholders and Wall Street – yet those profits never seem to be enough! So when it comes time to reform, restructure, realign, reinvent healthcare, then those with vested interests can prove difficult partners. It is this profit driven approach that really contributes to making healthcare reform in the US such a difficult process.

Not that this only applies to the US. In Europe, where a single payer is the norm (government funded model), money, or today, the lack of it, drives much of the healthcare agenda. Governments are desperate to cut the cost of healthcare delivery. Almost it seems at any cost. yet the barriers to change seem to be as mountainous as those in the US.

So, we have more than 50 million people without health coverage in the US, a plethora of corporations making billions of dollars of profit year on year, the rising cost of healthcare, the rise of medications and treatments that can cost up to $400,000 pa per patient and a general debate that the system is not sustainable. In Europe, countries are restricting the type of interventions delivered, delaying new innovations, cutting salaries of healthcare professionals and outsourcing as much as possible…..

And so it goes on.

There is a real perception, both in Europe and the US, that in order to continue to provide good quality healthcare, costs must continue their trajectory skyward. That better healthcare simply is going to cost more.

I disagree!

Foto de David MacKenzie Ogilvy (Photo credit: Wikipedia)

The well known advertising guru from years gone by – David Ogilvy – famously said that he knew 50% of his advertising spend was wasted, but that he didn’t know which half? Seems to me, the same applies. There is so much waste, duplication of effort, competing interests etc that it is hard for some people to believe that better healthcare does not have to cost more money.

This is the challenge for us all today. What do we need to do that will enable us to continue to deliver good health outcomes, or better health outcomes, to more people, without costing more?……….and so the debate continues.